OMNI Knee KC-36059Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841690101796), received between Feb 25, 2019 and Oct 7, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2019. THE ORIGINAL SURGERY IS DATED (B)(6) 2019. THE REASON FOR REVISION IS REPORTED PATIENT INFECTION. DURING THE REVISION, THE TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH A NEW FEMUR, INSERT, BASEPLATE AND PATELLA. IN ADDITION TWO REVISION STEMS WERE IMPLANTED ALONG WITH FOUR FEMORAL AUGMENTS AND AUGMENT BOLTS. THIS SURGERY WAS THE SECOND STAGE OF A TWO-STAGE REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 9164149 ↗
• InjuryFeb 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2019. THE ORIGINAL SURGERY IS DATED (B)(6) 2018. THE REVISION SURGERY OCCURRED BECAUSE OF A REPORTED INFECTION. DURING THE REVISION, THE TWO COMPONENTS USED AS A TEMPORARY SPACER, THE FEMORAL COMPONENT AND THE TIBIAL INSERT, WERE REMOVED AND REPLACED WITH A FULL OMNI REVISION KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 8366353 ↗